In this pilot study, the first objective is to bench test a novel shear reducing insole and compare it to current standard insoles and shoes. The second objective is to study twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for changes in spatial temporal gait including gait initiation, risk of falling, static and dynamic balance, and plantar temperature response to walking and consecutive plantar stress in both footwear conditions.

Plantar Foot Temperature Changes in Regions-of-interest in Response to Walking [ Time Frame: baseline and after 200 steps in each condition, this is a single visit study expected to last one hour ] [ Designated as safety issue: Yes ]

Plantar foot temperature changes in regions-of-interest in response to walking 200 steps will be measured in each footwear condition and compared to baseline.

Stride velocity during steady state dual task. Dual task used a simultaneous mental task while walking.

Double Support Time Single Task [ Time Frame: during each foot where condition up to 30 minutes ] [ Designated as safety issue: Yes ]

percentage of stride time spent in double support time during gait initiation. Double support time refers to the time spent with both feet on the ground. Single task means walking without a simultaneous mental task.

Double Support Time Dual Task Gait Initiation [ Time Frame: during each foot where condition up to 30 minutes ] [ Designated as safety issue: Yes ]

percentage of stride time spent in double support time during dual task conditions and during gait initiation. Double support time refers to the time spent with both feet on the ground. Dual task used a simultaneous mental task while walking.

Medial and Lateral Center of Mass Displacement Single Task [ Time Frame: under each foot where condition up to 30 minutes ] [ Designated as safety issue: Yes ]

Mediolateral (side-to-side) center of mass displacement with displacement in deg2 (degrees squared) under single task gait conditions. Single task means walking without a simultaneous mental task.

Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.

The industry standard diabetic innersole will be used as the active comparator

Other: Standard innersole

Experimental: Diabetic Foot Orthotic

The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.

Device: diabetic foot orthotic

The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.

Patients will be included if they have diabetes and have been referred for diabetic shoes. They will also be insensate with pre-ulcerative plantar callus or previous plantar foot ulcer.

Exclusion Criteria:

Patients will be excluded if they are unable to independently walk 100 feet, lower extremity prosthesis user, have active cellulitis, foot ulcer, or Charcot foot.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01844479